Study of Arsenic Trioxide in Small Cell Lung Cancer
The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in patients with small cell lung cancer who have failed at least one standard chemotherapy regimen as well as patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in this patient group. The study will include up to 36 participants with small cell lung cancer.
The investigators want to find out what effects, good or bad, that the study drug has on your cancer. This study will also look at specific biomarkers in your blood and in the tumor tissue which may help the investigators to determine if the levels of these biomarkers are related to tumor response to treatment.
Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more mature thereby stopping them from growing in number and more likely to die off.
Cancer of Lung
Carcinoma, Small Cell
Drug: Arsenic Trioxide
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm, Two-Stage Phase II Study of Arsenic Trioxide in Previously Treated Small Cell Lung Cancer|
- Response rate (RR) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Clinical Benefit Rate (CBR) [ Time Frame: After completing at least 1 cycle (8 weeks) of treatment ] [ Designated as safety issue: No ]Sum of CR, PR and SD in patients eligible for efficacy analysis.
- Progression-free survival [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: From enrolment till death on average up to 2 years ] [ Designated as safety issue: No ]Duration of time from enrollment on study until death
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Arsenic Trioxide Treatment
This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.
Drug: Arsenic Trioxide
Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470248
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Taofeek Owonikoko, MD, PhD||Emory University Winship Cancer Institute|